What is DAURISMO?
DAURISMO is a prescription medicine that is used with the medicine cytarabine to treat newly-diagnosed acute myeloid leukemia (AML) in adults who:
- are 75 years of age or older
- have other medical conditions that prevent the use of standard chemotherapy
DAURISMO has not been studied in people with severe kidney problems or moderate-to-severe liver problems.
What is the most important information I should know about DAURISMO?
DAURISMO can cause serious side effects. These serious side effects include:
- DAURISMO can cause your baby to die before it is born (be stillborn) or cause your baby to have severe birth defects.
- For females who can become pregnant:
- You should talk to your healthcare provider about the risks of DAURISMO to your unborn child.
- Your healthcare provider will do a pregnancy test within 7 days before you start taking DAURISMO.
- You should not use DAURISMO during pregnancy.
- You should use effective birth control during treatment and for at least 30 days after your last dose of DAURISMO. Talk with your healthcare provider about what birth control method is right for you during this time.
- Talk to your healthcare provider right away if you have unprotected sex or if you think that your birth control has failed.
- Tell your healthcare provider right away if you become pregnant or think that you may be pregnant.
- For males:
- It is not known if DAURISMO is present in semen. Do not donate semen during treatment with DAURISMO and for at least 30 days after your last dose.
- Tell your healthcare provider right away if your partner becomes pregnant or thinks she is pregnant while you are taking DAURISMO.
- You should always use effective birth control, including a condom, even if you have had a vasectomy, during sex with female partners who are pregnant or who are able to become pregnant, during treatment with DAURISMO and for at least 30 days after your last dose to protect your female partner from being exposed to DAURISMO.
- Changes in the electrical activity of your heart called QT prolongation. QT prolongation can cause irregular heartbeats that can be life-threatening. Tell your healthcare provider right away if you feel faint, lightheaded, dizzy, or feel your heart beating irregularly or fast during treatment with DAURISMO.
- The most common side effects of DAURISMO with cytarabine include:
- low red blood cell count (anemia)
- low platelet count
- tiredness
- shortness of breath
- bleeding
- decreased appetite
- swelling of arms or legs
- fever with low white blood cell count
- changes in taste
- muscle pain
- pain or sores in your mouth or throat
- nausea
- constipation
- rash
DAURISMO may affect fertility in males. Talk to your healthcare provider if this is a concern for you.
These are not all of the possible side effects of DAURISMO.
How should I take DAURISMO?
- Take DAURISMO with the medicine cytarabine exactly as your healthcare provider tells you.
- Take DAURISMO 1 time each day, at about the same time each day.
- Take DAURISMO with or without food.
- Do not chew, split or crush DAURISMO tablets.
- If you miss a dose, take it as soon as you remember. If it is less than 12 hours before your next dose, just skip the missed dose and take your next dose at your regular time. Do not take 2 doses of DAURISMO within 12 hours.
- If you vomit after taking a dose of DAURISMO, do not take an extra dose, just take your next dose at your regular time.
- Your healthcare provider will perform certain tests to check you for side effects before and during treatment with DAURISMO.
- Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with DAURISMO if you have certain side effects. Do not change your dose or stop taking DAURISMO unless your healthcare provider tells you.
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Important Safety Information
- Do not donate blood or blood products during treatment with DAURISMO and for at least 30 days after the last dose.
- Do not donate semen during treatment with DAURISMO and for at least 30 days after the last dose.
- DAURISMO may affect fertility in males. Talk to your healthcare provider if this is a concern for you.
- Do not breastfeed or provide breast milk to infants or children during treatment with DAURISMO and for at least 30 days after the last dose. Talk to your healthcare provider about the best way to feed your baby during this time
Ask your healthcare provider if you do not know.
What should I tell my healthcare provider before taking DAURISMO?
Before you take DAURISMO, tell your healthcare provider about all of your medical conditions, including if you:
- have heart problems, including a condition called long QT syndrome.
- abnormal blood salt (electrolytes) levels.
- are pregnant or plan to become pregnant.
- are breastfeeding or plan to breastfeed. It is not known if DAURISMO passes into your breast milk. Do not breastfeed or provide breast milk to infants or children during treatment with DAURISMO and for at least 30 days after the last dose. Talk to your healthcare provider about the best way to feed your baby during this time.
Tell your healthcare provider about the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements.
It is not known if DAURISMO is safe and effective in children.
General information about DAURISMO
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use DAURISMO for a condition for which it was not prescribed. Do not give DAURISMO to other people, even if they have the same symptoms that you have. It may harm them.
What are the ingredients in DAURISMO?
Active ingredient: Gasdegib
Other ingredient: Microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, and magnesium stearate.